Difluprednate ophthalmic emulsion 0.05% (Durezol) administered two times daily for managing ocular inflammation and pain following cataract surgery.

ABSTRACT:

Objective

To evaluate the efficacy and safety of twice-daily difluprednate ophthalmic emulsion 0.05% (Durezol(®)) versus placebo administered before surgery for managing inflammation and pain following cataract extraction.

Methods

Eligible subjects (N = 121) were randomized 2:1 to topical treatment with 1 drop difluprednate or placebo administered twice daily for 16 days, followed by a 14-day tapering period. Dosing was initiated 24 hours before unilateral ocular surgery. Clinical signs of inflammation (anterior chamber [AC] cell and flare grade, bulbar conjunctival injection, ciliary injection, corneal edema, and chemosis), ocular pain/discomfort, intraocular pressure (IOP), and adverse events were assessed.

Results

Clearing of inflammation on day 14 (primary endpoin

SUBMITTER: Smith S 

PROVIDER: S-EPMC2938279 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature